Full-Time
Manufacturing Specialist
Multiple Teams
Updated on 9/10/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Limited, periodic travel may be required for global stakeholder engagement.
Bachelor's, Master's, PhD
 Business & Strategy (1) |
|---|
Get referred to Amgen
See people who can refer or advise you
- A Doctorate, Master's, or Bachelor's degree and 8–13 years of experience.
- Deep subject matter expertise in one or more manufacturing domains, such as manufacturing execution systems, electronic batch records, finite scheduling and planning systems, sensing, data integration, digital control towers, performance management, or key performance indicator frameworks.
- Strong understanding of GxP environments, validation concepts, and data integrity principles.
- Ability to translate manufacturing processes into structured system and data requirements.
- Strong fluency in product management and modern delivery practices, including roadmapping, prioritization, user-centered design, and adoption at scale.
- Ability to work effectively with data engineers, developers, and user experience/user interface teams without being a coder.
- Strong problem-solving and analytical skills, attention to detail, and system-level thinking.
- Experience supporting system implementations, process improvements, or digital initiatives.
- Effective communication and collaboration skills in a cross-functional, global environment.
- Ability to manage multiple priorities and contribute to fast-paced, iterative delivery models.
- Support deployment of manufacturing capabilities at sites, including manufacturing execution system standardization, documentation automation, and performance management solutions.
- Participate in knowledge transfer, onboarding, and stabilization activities for transitioned capabilities.
- Work with site subject matter experts to capture process knowledge, system requirements, and operational constraints.
- Identify and escalate risks related to process gaps, system readiness, or compliance considerations.
- Translate manufacturing processes into structured system and data requirements.
- Define guardrails and design principles for automation, standardization, and scaling.
- Evaluate system impacts, dependencies, and integration requirements.
- Translate business needs into detailed functional requirements with senior managers, product leads, and subject matter experts.
- Partner with artificial intelligence/data, user experience/user interface, and engineering teams on solution alignment.
- Contribute to solution design, prototyping, and minimum viable product development.
- Validate that proposed solutions are fit for purpose, scalable, and aligned to enterprise standards.
- Assess requirements for GxP controls, validation, and documentation.
- Ensure requirements incorporate data integrity, auditability, and regulatory expectations.
- Support validation inputs and documentation requirements where applicable.
- Support use cases through the innovation lifecycle from intake and evaluation through minimum viable product, pilot, and scale.
- Contribute feasibility, constraints, and expected benefits to business cases.
- Participate in testing, user validation, and deployment activities.
- Support multi-site reuse and standardization of solutions.
- Collaborate with site subject matter experts, manufacturing leaders, and cross-functional partners.
- Act as a technical translator between manufacturing stakeholders and development teams.
- Communicate requirements, assumptions, and constraints clearly.
- Support global stakeholder engagement through limited, periodic travel as needed.
- At least four years of experience in biopharmaceutical manufacturing, manufacturing systems, or related technical roles.
- Expertise in manufacturing execution systems or electronic batch records, such as Körber PAS-X or similar systems.
- Experience with finite scheduling or planning systems, such as SAP PP/DS or S/4HANA.
- Experience with manufacturing data systems, sensing, or digital dashboards.
- Experience with manufacturing performance management and key performance indicator frameworks.
Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
Get referred to Amgen
See people who can refer or advise you
Simplify's Take
What believers are saying
- Q2 2026 revenue rose 10% to $10.1 billion, and guidance increased to $38.2 billion-$39.4 billion.
- Repatha sales jumped 37% to $953 million in Q2 2026, with U.S. prescriptions up 50%.
- MariTide advanced through multiple Phase 3 studies in 2026, supporting a 2027 obesity catalyst.
What critics are saying
- Prolia sales fell 32% in Q2 2026 as biosimilars attack Amgen’s legacy cash cow.
- FDA proposed withdrawing Tavneos in April 2026, signaling regulatory risk from integrity and efficacy issues.
- Olpasiran now faces Novartis pelacarsen failure scrutiny; a negative 2028 OCEAN(a) readout would crush Lp(a) upside.
What makes Amgen unique
- Repatha, Evenity, and Uplizna diversify Amgen beyond one blockbuster, per August 2026 sales.
- MariTide targets quarterly or eight-week dosing, unlike Lilly and Novo Nordisk weekly injections.
- Amgen’s 2027 Hyderabad Science and Innovation Center expands AI-enabled drug discovery globally.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Professional Development Budget
Conference Attendance Budget
Company News
Amgen trades at $393 per share, representing a trailing multiple of 23.3 times adjusted earnings. The biotech faces declining sales from Prolia and XGEVA, down 33% year-over-year to $1.1 billion in Q2 2026, due to biosimilar competition. Six key growth medicines grew 26% year-over-year, accounting for nearly 70% of Q2 product sales. Analysts forecast the forward multiple at 17.0 times for fiscal 2026 and 16.1 times for 2027. However, consensus assumes expanding profit margins whilst Amgen increases spending. Non-GAAP research spending is set to grow in high single digits for 2026, funding nine Phase III trials for MariTide, its obesity treatment candidate. Management warned of meaningful operating expense increases in Q3 2026. The valuation depends on margin expansion materialising during this investment phase.
Amgen faces heightened scrutiny for its experimental heart drug olpasiran after rival Novartis's pelacarsen failed to reduce major cardiovascular events in a Phase 3 trial, despite successfully lowering lipoprotein(a) levels. The setback demonstrates that improving laboratory biomarkers may not translate to better patient outcomes. Amgen's OCEAN(a) outcomes study has enrolled 7,297 participants and is tracking heart-related deaths and procedures over roughly five years. While olpasiran uses a different design and may target different patients, pelacarsen's failure removes assumptions about the commercial value of lowering Lp(a). Amgen's shares traded at $437.23, sitting 19.54% above its estimated fair value of $365.76. The company reported $10.1 billion in second-quarter revenue and $3.5 billion in free cash flow.
Jim Cramer highlighted Amgen's cholesterol drug Repatha as a key driver behind the company's 31% year-to-date rally, calling it an overlooked catalyst by Wall Street. The injectable treatment, administered every two weeks, reduces death risk by 20% in patients at high risk for heart attack or stroke. Repatha generated $953 million in second-quarter sales, up 37% year-over-year. US new prescriptions surged over 50%, split evenly between cardiologist use and primary-care adoption for high-risk patients. Cramer noted the drug works against diabetes and high cholesterol, though insurance reimbursement has posed challenges. Amgen trades at a forward PE of 19, compared to Eli Lilly's 32, whilst outperforming Lilly's 10% gain this year. Repatha is one of six growth drivers representing nearly 70% of Amgen's product sales. The company raised full-year revenue guidance to $38.2-$39.4 billion.
Amgen shares jumped 3.5% to $440.08 on Wednesday as healthcare stocks reached record highs. The biotech company reported second-quarter revenue of $10.1 billion, up 10%, whilst GAAP earnings surged 65% to $4.37 per share. Twenty-two of Amgen's medicines posted double-digit sales growth, with seventeen products generating over $1 billion in annualised sales. Six key growth products climbed 26% and now account for nearly 70% of product revenue. The rally came as investors rotated into healthcare following excitement around Merck and Moderna's melanoma breakthrough. However, Amgen now trades at a 19% premium to its fair value estimate of $365.04, putting pressure on execution as some products like Prolia face headwinds.
Amgen and Regeneron could benefit from surging demand for GLP-1 drugs, which traditionally treated diabetes but now address obesity and obstructive sleep apnea. Amgen's stock is up 27% this year, with second-quarter revenue rising 10% year-over-year to $10.1 billion. The company is testing MariTide, an investigational GLP-1 medicine, in phase 3 studies for weight management and diabetes. MariTide could be administered monthly or less frequently, offering a convenience advantage over current daily or weekly treatments. Regeneron is also positioned to capitalise on the GLP-1 market expansion. Both companies present alternatives to current market leaders Eli Lilly and Novo Nordisk for investors seeking exposure to the growing GLP-1 drug category.